Safety Study of Intratumoral Injection of Clostridium Novyi-NT Spores to Treat Patients With Solid Tumors That Have Not Responded to Standard Therapies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01924689
Recruitment Status : Completed
First Posted : August 16, 2013
Last Update Posted : May 14, 2018
Information provided by (Responsible Party):
BioMed Valley Discoveries, Inc

Brief Summary:
This protocol will examine the safety of intratumoral administration of Clostridium Novyi-NT spores in patients with treatment-refractory solid tumor malignancies. This investigational study will measure anti-tumor activity of C. novyi-NT administered intratumoral in patients with treatment-refractory solid tumor malignancies.

Condition or disease Intervention/treatment Phase
Solid Tumor Malignancies Biological: Clostridium novyi-NT spores Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Safety Study of Intratumoral Injection of Clostridium Novyi-NT Spores in Patients With Treatment-refractory Solid Tumor Malignancies
Study Start Date : October 2013
Actual Primary Completion Date : October 31, 2017
Actual Study Completion Date : October 31, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Clostridium novyi-NT spores Biological: Clostridium novyi-NT spores
Phase 1 study: It will be an escalating dose design, with no intracohort escalation. The first cohort dose will begin at 1 x 10(4) spores/kg and will escalate by tripling through 5 cohorts up to 100 x 10(4) spores/kg.
Other Names:
  • bacteria
  • anaerobic bacteria

Primary Outcome Measures :
  1. Safety and tolerability of C. novyi-NT spore administration in patients with advanced solid tumor malignancies will be measured over a 8-day inpatient admission with routine labs, imaging (CT or MRI) assessments and continuous adverse event assessments. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Anti-tumor activity of C. novyi-NT spores will be assessed with serial imaging studies such as CT scans, MRI and blood-based tumor markers. [ Time Frame: 2 years ]
  2. Pharmacokinetics of the C. novyi-NT spores will be measured in routine blood sampling over the course of the study. [ Time Frame: 2 years ]
  3. The host immune and inflammatory response to C. novyi-NT spores will be measured in routine blood sampling over the course of the study. [ Time Frame: 2 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Diagnosis of an advanced solid tumor malignancy. There must be a target tumor which is measureable, palpable or clearly identifiable under ultrasound or radiographic guidance and amenable to percutaneous injection of C. novyi-NT spores. The targeted lesion must have a longest diameter ≥ 1 cm and ≤ 12 cm and be measurable as defined by RECIST 1.1 criteria. The target lesion must not be located in either the thoracic, abdominal or pelvic cavities or in the brain. There must be no clinical, no functional, and no radiographic evidence of bone involvement at the site of the target lesion.
  2. History of prior treatment with at least one line of systemic anticancer therapy, when an approved systemic therapy is available, and no curative option is available for continued treatment.
  3. At least 4 weeks have elapsed since the completion of major surgery, and the patient has fully recovered from this surgery and any post-surgical complications.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less.
  5. Patient is at least 18 years of age.
  6. Patient is capable of giving informed consent.
  7. Patient of childbearing potential (defined by the clinical sites' standards) is using adequate birth control measures (e.g., barrier method with spermicide; intrauterine device; implantable or injectable hormonal contraceptives; surgical sterilization) for the duration of the study and will continue to use such precautions for 12 months after receiving treatment.
  8. Patient has no significant valvular heart disease (trace or mild valvular stenosis or regurgitation is allowed).
  9. Patient is able to stay within 45 minutes driving time of an emergency room for 28 days after doing.
  10. The patient has a caregiver for 28 days after dosing.

Exclusion Criteria:

  1. Positive pregnancy test.
  2. Serum creatinine level > 1.5 x the upper limit of normal (ULN), chronic renal failure requiring hemodialysis or peritoneal dialysis.
  3. Patient has any of the following hematologic parameters:

    • Platelet count equal to or less than 100,000/mm3
    • Hemoglobin less than 9.0 g/dL
    • Absolute neutrophil count (ANC) less than 1,000 /mm3
  4. Oxygen saturation (Sp02) of less than 95% on room air.
  5. Mean arterial blood pressure (BP) of less than 70 mmHg.
  6. Glasgow Coma Score (GCS) of less than 15.
  7. Treatment with an investigational drug within the past 30 days or 5 half-lives of that drug, whichever is shorter.
  8. Documented primary brain malignancy or brain metastases.
  9. Clinically significant ascites or clinical evidence or history of portosystemic hypertension or cirrhosis.
  10. Laboratory evidence of hepatic dysfunction indicated by any of the following:

    • Bilirubin ≥ 1.5 x the ULN
    • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) above 2.5X the ULN
    • Alkaline phosphatase above 2.5X the ULN
    • International normalized ratio (INR) greater than 1.3
  11. Patient has a foreign body which in the opinion of the treating investigator could be difficult to manage in case of infection (e.g. prosthetic hip).
  12. Clinically significant pleural effusion.
  13. Clinically significant pericardial effusion, circumferential pericardial effusion, or any effusion greater than 1.0 cm at any location around the heart.
  14. Need for ongoing treatment with an immunosuppressive agent.
  15. History of solid organ transplantation (with the exception of a corneal transplant > 3 months prior to screening).
  16. History of an ischemic insult in the previous 12 months (myocardial infarction, cerebral vascular accident, ischemic tissue from injury, transient ischemic attack.
  17. History of a significant medical illness deemed by the PI or local investigators as unsuitable for the trial. For example:

    i. Symptomatic congestive heart failure ii. Psychiatric Illness/social situation that may make study dangerous iii. Unstable angina pectoris

  18. Asplenia.
  19. Antibiotic allergies that would preclude treatment for a C. novyi-NT infection.
  20. Treatment with antibiotics within 2 weeks (14 days) of dosing.
  21. Active and clinically significant systemic or localized infection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01924689

United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Texas
UT M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
BioMed Valley Discoveries, Inc

Responsible Party: BioMed Valley Discoveries, Inc Identifier: NCT01924689     History of Changes
Other Study ID Numbers: BVDCNV2
First Posted: August 16, 2013    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018

Keywords provided by BioMed Valley Discoveries, Inc:
Phase 1
Metastatic Disease
Solid Tumor
Clinical Trial
Locally advanced cancer

Additional relevant MeSH terms: